EP3714917A1 - Servicesystem für extrakorporale zirkulationsvorrichtungen und entsprechendes verfahren zur verhinderung der proliferation von bakterienpopulationen - Google Patents

Servicesystem für extrakorporale zirkulationsvorrichtungen und entsprechendes verfahren zur verhinderung der proliferation von bakterienpopulationen Download PDF

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Publication number
EP3714917A1
EP3714917A1 EP20161523.4A EP20161523A EP3714917A1 EP 3714917 A1 EP3714917 A1 EP 3714917A1 EP 20161523 A EP20161523 A EP 20161523A EP 3714917 A1 EP3714917 A1 EP 3714917A1
Authority
EP
European Patent Office
Prior art keywords
service
tank
exchanger
ozone
liquid
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP20161523.4A
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English (en)
French (fr)
Inventor
Stefano PROVASI
Gino ALBORESI
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Tecnoline SpA
Original Assignee
Tecnoline SpA
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Tecnoline SpA filed Critical Tecnoline SpA
Publication of EP3714917A1 publication Critical patent/EP3714917A1/de
Withdrawn legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/168—Sterilisation or cleaning before or after use
    • A61M1/169—Sterilisation or cleaning before or after use using chemical substances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
    • A61L2/18—Liquid substances or solutions comprising solids or dissolved gases
    • A61L2/183—Ozone dissolved in a liquid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/168—Sterilisation or cleaning before or after use
    • A61M1/1688—Sterilisation or cleaning before or after use with recirculation of the sterilising fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3666—Cardiac or cardiopulmonary bypass, e.g. heart-lung machines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/10—Apparatus features
    • A61L2202/11—Apparatus for generating biocidal substances, e.g. vaporisers, UV lamps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/20—Targets to be treated
    • A61L2202/24—Medical instruments, e.g. endoscopes, catheters, sharps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/11—General characteristics of the apparatus with means for preventing cross-contamination when used for multiple patients
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/36—General characteristics of the apparatus related to heating or cooling
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/36—General characteristics of the apparatus related to heating or cooling
    • A61M2205/366—General characteristics of the apparatus related to heating or cooling by liquid heat exchangers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/75—General characteristics of the apparatus with filters
    • A61M2205/7518—General characteristics of the apparatus with filters bacterial

Definitions

  • the present invention relates to a service system, for extracorporeal circulation apparatuses, and a corresponding method for preventing the proliferation of bacterial population.
  • this bacterium constitutes a severe threat to persons who undergo cardiac surgery, for whom, in order to provide a temporary extracorporeal circulation, use is made of machines for heating and cooling the blood, and these machines can be colonized by the bacterium.
  • Such machines in fact have circuits that are passed through by water (used to exchange heat with the blood), which can contain the chimaera bacterium.
  • water used to exchange heat with the blood
  • the bacterium Owing to the stagnation of water vapor in ducts and/or as a consequence of the fall of water droplets in the operating theater (for example during the steps of preparation or cleaning of the machine), the bacterium can spread in the operating theater and/or infect the patient, in particular the cardiac valves, where it can lie dormant for several years and then flare up, causing extremely serious inflammatory diseases which can have a lethal outcome.
  • Such methods in fact comprise requiring the daily change of the water that passes through the circuits and/or the frequent use of chemical disinfectants, to be mixed with the water.
  • these solutions are very laborious, as they involve an unwanted expenditure of time and, where they use chemical disinfectants, they also have other contraindications.
  • the aim of the present invention is to solve the above mentioned problems, by providing a service system that ensures practical means of preventing infections by mycobacterium chimaera.
  • an object of the invention is to provide a system and/or propose a method that makes it possible to sanitize and disinfect, simply and completely, circuits and machines involved in extracorporeal circulation.
  • Another object of the invention is to provide a system that ensures a high reliability of operation and which can be easily implemented, starting with elements and materials readily available on the market.
  • Another object of the invention is to provide a system that adopts an alternative technical and structural architecture to those of conventional systems.
  • Another object of the invention is to provide a method that can be easily implemented starting with elements and materials readily available on the market.
  • Another object of the invention is to provide a system and/or a method that are of low cost and safely applied.
  • the reference numeral 1 generally designates a service system, which can be implemented and/or used for extracorporeal circulation apparatuses (which are conventional), which may be already present in operating theaters.
  • extracorporeal circulation apparatuses are biomedical machines, used mostly in cardiac surgery to ensure the survival of the patient during the operation, temporarily standing in for the patient's cardiopulmonary functions.
  • the system 1 therefore comprises at least one heat exchanger 2, which is passed through (typically, but not exclusively, cyclically) by blood destined for extracorporeal circulation, and by a service liquid A, and which has the task of heating and/or cooling that blood (circulating within the exchanger 2), as a function of the specific requirements and surgical necessities.
  • service liquid A is typically water (optionally with additives of various kinds), although the possibility is not ruled out of using other liquids A, while remaining within the scope of protection claimed herein.
  • the system 1 further comprises at least one tank 3 for containing the service liquid A.
  • system 1 comprises a delivery branch 4 which is normally interposed between the tank 3 and the exchanger 2, in order to ensure the liquid A is sent to the exchanger 2 (typically, by way of a pump 5).
  • the system 1 likewise comprises a return branch 6, which is normally interposed between the exchanger 2 and the tank 3, in order to allow the return of the liquid A to the tank 3.
  • the exchanger 2, the tank 3 and the branches 4, 6 (interposed between the exchanger 2 and the tank 3) form a service circuit 7a, which is normally passed through by the service liquid A (typically cyclically).
  • the service circuit 7a (and more generally the system 1) can comprise a number at will of tanks 3 (for example three, as in Figure 1 ), which are mutually connected in series or in parallel and which in any case are interposed between the branches 4, 6).
  • system 1 and the service circuit 7a defined above are substantially conventional, and one of the objectives of the invention is in fact to be able to intervene easily in existing solutions as well, or in any case intervening in line with existing solutions, in any case ensuring an effective prevention of chimaera bacterium infections, and more besides.
  • the system 1 comprises a unit 8 for dispensing ozone, which can be of the commercial type (supplied with a bottle of oxygen for example) or specially made, according to the specific requirements.
  • the ozone generation unit 8 comprises an oxygen enrichment device, for subsequently generating ozone starting from atmospheric air.
  • the system 1 comprises a filtering assembly 9, which in turn comprises a tubular body 10 which can be connected to the tank 3 (or to the tanks 3) through the branches 4, 6 as a temporary replacement for the exchanger 2 (i.e., having previously taken care to disconnect the branches 4, 6 from the latter), in order to provide a temporary circuit 7b, for disinfection.
  • the temporary circuit 7b comprises the assembly 9 (the body 10), the tank 3 and the branches 4, 6.
  • the body 10 is affected by at least one filter 11 for the service liquid A and by a connector 12 for mixing the liquid A with the ozone dispensed by the unit 8.
  • the mixture of liquid A and ozone is typically (but not exclusively) kept heterogeneous, insofar as the ozone is also in the gaseous phase.
  • the connector 12 is arranged downstream of the filter 11.
  • the filter 11 is arranged directly upstream of the connector 12, at which the ozone is introduced into the temporary circuit 7b.
  • the mixture of water and ozone affects the filter 11 only after having almost completely passed through the temporary circuit 7b, and therefore after having accumulated the maximum quantity of impurities.
  • the possibility is not ruled out however of arranging the connector 12 upstream of the filter 11, or in any case in any other position.
  • the connector 12 can be a "Y" connector of various types, and can be conveniently contoured so as to increase the speed of the gas by the Venturi effect, at its mixing with water (or other service liquid A).
  • the filter 11 is an antibacterial filter and/or is constituted by a microporous filtering membrane (in any case the possibility of choosing further embodiments of the filter 11 comes under the scope of protection claimed herein).
  • the filtering assembly 9 comprises an ozone diffuser 13, which is arranged along the tubular body 10 (and preferably but not exclusively made of ceramic).
  • the function of the diffuser 13 is to diffuse the ozone in the form of bubbles of very small average size, thus boosting the oxidant and disinfectant action (and the capacity to separate the slime and impurities from the inner walls of the conduits that it steadily flows over).
  • the protection is claimed of the supply and/or marketing of only the components that need to be used in substitution of the exchanger 2, in order to provide the temporary circuit 7b (the other components can be pre-existing).
  • the object of the present discussion, and of the protection claimed herein, also relates to a method for preventing the proliferation of bacterial population, for service circuits 7a of extracorporeal circulation apparatuses.
  • the service circuits 7a on which the method according to the invention is carried out are effectively of the type explained above. More generally, it must be noted that the method according to the invention can be carried out on systems 1 and/or by using kits according to the invention, as already described in the foregoing pages.
  • the method according to the invention can be carried out on one or more service circuits 7a which are normally passed through by a service liquid A (preferably but not exclusively water).
  • the service circuits 7a comprise at least one heat exchanger 2, which is passed through by blood destined for extracorporeal circulation (preferably, but not exclusively, cyclically), so that it can be heated and/or cooled by that service liquid A.
  • the service circuits 7a comprise at least one tank 3 (or multiple tanks 3) for containing the liquid A, a delivery branch 4 and a return branch 6, with these branches interposed between the exchanger 2 and the tank 3.
  • the service circuits 7a on which the method according to the invention is carried out also include a pump 5, which is arranged along the delivery branch 4.
  • the method consists first of all of a step a., of disconnecting the exchanger 2 from the branches 4, 6.
  • the method entails connecting the tubular body 10 of a filtering assembly 9, which is provided with at least one filter 11, to the tank 3 via the branches 4, 6, so as to provide a temporary disinfection circuit 7b which comprises the tank 3, the tubular body 10 and the branches 4, 6.
  • the method then entails, in a step c., sending ozone to the tubular body 10, preferably at a connector 12 which is fitted on the body 10.
  • the method then consists of a step d., of circulating (for example, by way of the pump 5) the service liquid A, mixed with the ozone, in the temporary circuit 7b.
  • the activity d. can be prolonged for the length of time deemed necessary to adequately treat the liquid A, the tanks 3, the branches 4, 6 and any other component that may be comprised in the temporary circuit 7b. It is also possible that within the execution of the step d., the liquid can flow multiple times, cyclically, through the temporary circuit 7b.
  • the method according to the invention entails, in a step e., the disconnection of the tubular body 10 from the branches 4, 6 and the reconnection to the exchanger 2, in order to restore the service circuit 7a, thus making it available to the extracorporeal circulation apparatus with which it is intended to be used.
  • the exchanger 2 will be passed through by water (or other service liquid A) which has previously been treated with ozone and therefore the risk of contact of the blood with water that is infected or otherwise rich in potentially hazardous microorganisms is guarded against, as is the risk of stagnation of vapor carrying microbial colonies.
  • FIG. 1 schematically shows the possibility of providing and connecting/disconnecting the circuits 7a, 7b: in this regard, it should be specified that the steps a., b., e. of connecting and disconnecting the exchanger 2 and of the body 10 can be carried out manually by an operator, just as the possibility is not ruled out of using automatic or semi-automatic solutions.
  • the step c. entails sending a predefined quantity of ozone to the tubular body 10, continuously, for a time comprised between 1 minute and 30 minutes, and preferably for a time comprised between 5 minutes and 10 minutes, and even more preferably for 5 minutes.
  • the predefined quantity of ozone to be sent in the period of time just defined is comprised between 50 mg and 150 mg and is preferably equal to 50 mg (although other values are not ruled out, for the duration of the step and/or the quantity of ozone).
  • the step c. can be carried out using the previously-described unit 8, which is provided for example with a controller or other electronic device for control and management, which is preset and/or freely reconfigurable to dispense ozone according to the time and/or quantity parameters described above.
  • step c. Whatever the duration of execution of the step c., it can be carried out in at least partial simultaneity with the step d., and therefore the dispensing of the ozone will be maintained while the pump 5 is already in operation, or in any case while the liquid A is moving in the temporary circuit 7b.
  • the scope of protection claimed herein covers the possibility that the step d. is carried out before starting step c.: in other words, moving the liquid A can begin even before introducing ozone into the temporary circuit 7b.
  • the method according to the invention can preferably entail that the steps a., b., c., d. and e. (and therefore the disinfection treatment obtained by circulating ozone in the temporary circuit 7b) be repeated periodically according to a preset interval (for example every 1, 2 or 3 days at a scheduled time).
  • a preset interval for example every 1, 2 or 3 days at a scheduled time.
  • the ozone (in gaseous form) is injected into the temporary circuit 7b thus created, at the connector 12, is mixed with the water and from there it flows through the branches 4, 6 and each tank 3, as explained previously performing on these (and on the water) its oxidant and disinfectant action, on the mycobacterium chimaera and more besides.
  • the assembly 9 After having left the ozone to act for the desired length of time, the assembly 9 is disconnected and the exchanger 2 is reconnected to the branches 4, 6, thus restoring the service circuit 7a which is now certainly free from pathogens (and also from other impurities that may be dissolved in water and/or accumulated over time along the inner walls of the conduits involved). It will moreover be possible to remove the filter 11 from the assembly 9 and/or in any case clean the filter, in order to free it from the residues and from the accumulated detritus, thus making it available for another use.
  • ozone is an unstable substance, and therefore its useful action ends (typically after about twenty to thirty minutes) when it is converted back to oxygen, without leaving harmful traces, if any, in the service circuit 7a and without causing any damage to the machines of the extracorporeal circulation apparatus.
  • system 1 and/or the method according to the invention ensure practical means of preventing infections by mycobacterium chimaera and of preventing the proliferation of bacterial population in general.
  • ozone is first and foremost capable of treating and disinfecting the water that circulates along the temporary circuit 7b, and therefore along the service circuit 7a, once the latter has been restored for the activation of extracorporeal circulation. Furthermore, ozone can be liberated above the surface of the water in the tanks 3, performing its useful function on all the walls (including the ceiling) of these tanks, thus preventing or destroying the formation of colonies of bacteria in any part of the system 1.
  • any stagnation of water vapor does not represent a threat to the health of individuals (and of patients in particular), since, having first been subjected to the circulation of ozone, the water is safe, being free from microorganisms (chimaera and/or others).
  • the materials employed, as well as the dimensions, may be any according to requirements and to the state of the art.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Urology & Nephrology (AREA)
  • Veterinary Medicine (AREA)
  • Vascular Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Anesthesiology (AREA)
  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Cardiology (AREA)
  • Emergency Medicine (AREA)
  • Pulmonology (AREA)
  • Epidemiology (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)
EP20161523.4A 2019-03-25 2020-03-06 Servicesystem für extrakorporale zirkulationsvorrichtungen und entsprechendes verfahren zur verhinderung der proliferation von bakterienpopulationen Withdrawn EP3714917A1 (de)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
IT102019000004237A IT201900004237A1 (it) 2019-03-25 2019-03-25 Sistema di servizio, per apparati di circolazione extracorporea, e relativo procedimento di prevenzione della crescita della popolazione batterica.

Publications (1)

Publication Number Publication Date
EP3714917A1 true EP3714917A1 (de) 2020-09-30

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EP20161523.4A Withdrawn EP3714917A1 (de) 2019-03-25 2020-03-06 Servicesystem für extrakorporale zirkulationsvorrichtungen und entsprechendes verfahren zur verhinderung der proliferation von bakterienpopulationen

Country Status (2)

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EP (1) EP3714917A1 (de)
IT (1) IT201900004237A1 (de)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE4138140A1 (de) * 1991-11-20 1993-05-27 Fresenius Ag Vorrichtung zur desinfektion von haemodialysegeraeten mit einem pulverfoermigen konzentrat
US6076808A (en) * 1996-04-30 2000-06-20 Porter; Brooks S. Apparatus for producing ozonated water
EP2698176A1 (de) * 2012-08-13 2014-02-19 Sorin Group Deutschland GmbH Verfahren und Vorrichtung zur Desinfizierung einer Temperatursteuerungsvorrichtung für die menschliche Körpertemperatursteuerung während der extrakorporalen Zirkulation

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE4138140A1 (de) * 1991-11-20 1993-05-27 Fresenius Ag Vorrichtung zur desinfektion von haemodialysegeraeten mit einem pulverfoermigen konzentrat
US6076808A (en) * 1996-04-30 2000-06-20 Porter; Brooks S. Apparatus for producing ozonated water
EP2698176A1 (de) * 2012-08-13 2014-02-19 Sorin Group Deutschland GmbH Verfahren und Vorrichtung zur Desinfizierung einer Temperatursteuerungsvorrichtung für die menschliche Körpertemperatursteuerung während der extrakorporalen Zirkulation

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